Identification of false asystole detection

ABSTRACT

This disclosure is directed to techniques for identifying false detection of asystole in a cardiac electrogram that include determining whether at least one of a plurality of false asystole detection criteria are satisfied. In some examples, the plurality of false asystole detection criteria includes a first false asystole detection criterion including a reduced amplitude threshold for detecting cardiac depolarizations in the cardiac electrogram, and a second false asystole detection criterion for detecting decaying noise in the cardiac electrogram.

This application is a continuation of U.S. patent application Ser. No.16/401,553, filed May 2, 2019. The entire content of application Ser.No. 16/401,553 is incorporated herein by reference.

FIELD

The disclosure relates generally to medical systems and, moreparticularly, medical systems configured to detect asystole based on acardiac electrogram.

BACKGROUND

Some types of medical devices may monitor a cardiac electrogram (EGM) ofa patient to monitor the electrical activity of the patient's heart. Acardiac EGM is an electrical signal sensed via electrodes. In someexamples, the medical devices monitor a cardiac EGM to detect one ormore types of arrhythmia, such as bradycardia, tachycardia,fibrillation, or asystole (e.g., caused by sinus pause or AV block).

SUMMARY

A cardiac EGM may include noise in addition to the signal representingthe electrical activity of the heart. Additionally, the amplitude of thesignal representing the electrical activity of the heart within thecardiac EGM may vary over time, e.g., due to movement of the electrodesrelative to the cardiac tissue. Noise and signal amplitude variationsmay confound detection of arrhythmias, such as asystole, using thecardiac EGM.

In general, the disclosure is directed to techniques for identifyingfalse detection of asystole in a cardiac electrogram. The techniquesinclude analyzing the cardiac EGM to determine whether at least one of aplurality of false asystole detection criteria are satisfied. In someexamples, processing circuity of a medical device system performs thisanalysis in response to an asystole detection criterion being satisfied,and may determine whether to provide or withhold an indication (e.g., toa clinician or other user) that the patient experienced asystole basedon the analysis. In this manner, the techniques of this disclosure mayadvantageously enable improved accuracy in the identification of trueasystole and, consequently, better evaluation of the condition of thepatient.

In one example, a medical system comprises a plurality of electrodesconfigured to sense a cardiac electrogram of a patient; and processingcircuitry. The processing circuitry is configured to determine that anasystole detection criterion is satisfied based on the cardiacelectrogram and, based on the determination that the asystole detectionis satisfied, determine whether a plurality of false asystole detectioncriteria are satisfied based on the cardiac electrogram signal. Theprocessing circuitry is further configured to withhold an indication ofan asystole episode for the patient based on a determination that atleast one of the plurality of false asystole detection criteria issatisfied. The plurality of false asystole detection criteria comprisesa first false asystole detection criterion including a reduced amplitudethreshold for detecting cardiac depolarizations in the cardiacelectrogram, and a second false asystole detection criterion fordetecting decaying noise in the cardiac electrogram.

In another example, a method comprises sensing a cardiac electrogram ofa patient via a plurality of electrodes of a medical system, anddetermining, by processing circuitry of the medical system, that anasystole detection criterion is satisfied based on the cardiacelectrogram. The method further comprises, based on the determinationthat the asystole detection is satisfied, determining, by the processingcircuitry, that at least one of a plurality of false asystole detectioncriteria are satisfied based on the cardiac electrogram signal, andwithholding, by the processing circuitry, an indication of an asystoleepisode for the patient based on a determination that at least one ofthe plurality of false asystole detection criteria is satisfied. Theplurality of false asystole detection criteria comprises a first falseasystole detection criterion including a reduced amplitude threshold fordetecting cardiac depolarizations in the cardiac electrogram, and asecond false asystole detection criterion for detecting decaying noisein the cardiac electrogram.

In another example, a non-transitory computer-readable storage mediumcomprises program instructions that, when executed by processingcircuitry of a medical system, cause the processing circuitry todetermine that an asystole detection criterion is satisfied based on acardiac electrogram sensed via a plurality of electrodes of the medicalsystem. Based on the determination that the asystole detection issatisfied, the program instructions cause the processing circuitry todetermine whether a plurality of false asystole detection criteria aresatisfied based on the cardiac electrogram signal, and withhold anindication of an asystole episode for the patient based on adetermination that at least one of the plurality of false asystoledetection criteria is satisfied. The plurality of false asystoledetection criteria comprises a first false asystole detection criterionincluding a reduced amplitude threshold for detecting cardiacdepolarizations in the cardiac electrogram, and a second false asystoledetection criterion for detecting decaying noise in the cardiacelectrogram.

The summary is intended to provide an overview of the subject matterdescribed in this disclosure. It is not intended to provide an exclusiveor exhaustive explanation of the systems, device, and methods describedin detail within the accompanying drawings and description below.Further details of one or more examples of this disclosure are set forthin the accompanying drawings and in the description below. Otherfeatures, objects, and advantages will be apparent from the descriptionand drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates the environment of an example medical system inconjunction with a patient.

FIG. 2 is a functional block diagram illustrating an exampleconfiguration of the implantable medical device (IMD) of the medicalsystem of FIG. 1.

FIG. 3 is a conceptual side-view diagram illustrating an exampleconfiguration of the IMD of FIGS. 1 and 2.

FIG. 4 is a functional block diagram illustrating an exampleconfiguration of the external device of FIG. 1.

FIG. 5 is a block diagram illustrating an example system that includesan access point, a network, external computing devices, such as aserver, and one or more other computing devices, which may be coupled tothe IMD and external device of FIGS. 1-4.

FIG. 6 is a flow diagram illustrating an example operation fordetermining whether an identification of an asystole episode was falsebased on whether a plurality of false asystole detection criteria issatisfied.

FIG. 7 is a graph illustrating a cardiac EGM associated with anidentified asystole episode and an example technique for determiningwhether an example false asystole detection criterion is satisfied basedon the cardiac EGM.

FIG. 8 is a flow diagram illustrating an example operation fordetermining whether an example false asystole criterion that includes areduced amplitude threshold for depolarization detection is satisfied.

FIG. 9 is a graph illustrating a cardiac EGM that includes decayingnoise.

FIG. 10 is a graph illustrating a cardiac EGM that includes decayingnoise and an example technique for determining whether an example falseasystole detection criterion is satisfied based on the cardiac EGM.

FIG. 11 is a flow diagram illustrating an example operation fordetermining whether an example false asystole criterion for detectingdecaying noise is satisfied.

FIG. 12 is a graph illustrating a differential signal of a cardiac EGMthat includes decaying noise and an example technique for determiningwhether an example false asystole detection criterion is satisfied basedon the cardiac EGM.

FIG. 13 is a flow diagram illustrating another example operation fordetermining whether an example false asystole criterion for detectingdecaying noise is satisfied.

FIG. 14 is a graph illustrating a cardiac EGM associated with anidentified asystole episode and an example technique for determiningwhether another example false asystole detection criterion is satisfiedbased on the cardiac EGM.

FIG. 15 is a flow diagram illustrating another example operation fordetermining whether an example false asystole criterion is satisfied.

FIG. 16 is a graph illustrating a cardiac EGM associated with anidentified asystole episode and an example technique for determiningwhether another example false asystole detection criterion is satisfiedbased on the cardiac EGM.

FIG. 17 is a flow diagram illustrating another example operation fordetermining whether an example false asystole criterion is satisfied.

FIG. 18A is a conceptual drawing illustrating a front view of a patientwith another example medical system.

FIG. 18B is a conceptual drawing illustrating a side view of the patientwith the example medical system of FIG. 18A.

FIG. 18C is a conceptual drawing illustrating a transverse view of thepatient with the example medical system of FIG. 18A.

Like reference characters denote like elements throughout thedescription and figures.

DETAILED DESCRIPTION

A variety of types of medical devices sense cardiac EGMs. Some medicaldevices that sense cardiac EGMs are non-invasive, e.g., using aplurality of electrodes placed in contact with external portions of thepatient, such as at various locations on the skin of the patient. Theelectrodes used to monitor the cardiac EGM in these non-invasiveprocesses may be attached to the patient using an adhesive, strap, belt,or vest, as examples, and electrically coupled to a monitoring device,such as an electrocardiograph, Holter monitor, or other electronicdevice. The electrodes are configured to sense electrical signalsassociated with the electrical activity of the heart or other cardiactissue of the patient, and to provide these sensed electrical signals tothe electronic device for further processing and/or display of theelectrical signals. The non-invasive devices and methods may be utilizedon a temporary basis, for example to monitor a patient during a clinicalvisit, such as during a doctor's appointment, or for example for apredetermined period of time, for example for one day (twenty-fourhours), or for a period of several days.

External devices that may be used to non-invasively sense and monitorcardiac EGMs include wearable devices with electrodes configured tocontact the skin of the patient, such as patches, watches, or necklaces.One example of a wearable physiological monitor configured to sense acardiac EGM is the SEEQ™ Mobile Cardiac Telemetry System, available fromMedtronic plc, of Dublin, Ireland. Such external devices may facilitaterelatively longer-term monitoring of patients during normal dailyactivities, and may periodically transmit collected data to a networkservice, such as the Medtronic Carelink™ Network.

Implantable medical devices (IMDs) also sense and monitor cardiac EGMs.The electrodes used by IMDs to sense cardiac EGMs are typicallyintegrated with a housing of the IMD and/or coupled to the IMD via oneor more elongated leads. Example IMDs that monitor cardiac EGMs includepacemakers and implantable cardioverter-defibrillators, which may becoupled to intravascular or extravascular leads, as well as pacemakerswith housings configured for implantation within the heart, which may beleadless. An example of pacemaker configured for intracardiacimplantation is the Micra™ Transcatheter Pacing System, available fromMedtronic plc. Some IMDs that do not provide therapy, e.g., implantablepatient monitors, sense cardiac EGMs. One example of such an IMD is theReveal LINQ™ Insertable Cardiac Monitor, available from Medtronic plc,which may be inserted subcutaneously. Such IMDs may facilitaterelatively longer-term monitoring of patients during normal dailyactivities, and may periodically transmit collected data to a networkservice, such as the Medtronic Carelink™ Network.

Regardless of which type or types of devices are used, a noise signal,which may be referred to as an artifact, may appear in the cardiac EGM.The time duration of the noise signal may extend over a portion of anormal timeframe for a cardiac cycle of the heart, or may extend over atime span during which multiple cardiac cycles may be expected to haveoccurred. Such noise signals may be more prevalent when cutaneous,subcutaneous, or extravascular electrodes are used to sense the cardiacEGM, e.g., due to temporary change in contact between at least one ofthe electrodes and the tissue where the electrode is located due torelative motion of the electrode and tissue. In some examples, the noisesignal manifests as a baseline drift of the cardiac EGM, and may includea portion that decays back towards the steady-state baseline.

The presence of a noise signal in a sensed cardiac EGM may causecircuitry for detecting depolarizations, e.g., R-waves, to wronglydetect the noise signal as a depolarization. The noise signal may alsocause the circuitry to then fail to sense a number of subsequentdepolarizations because the noise signal may be much bigger in amplitudethan the subsequent depolarizations and, in some cases, because thehigh-amplitude noise may cause an adjustable sensing threshold used bythe circuitry to be adjusted to a level greater than the amplitude ofthe true depolarizations. Additionally, the amplitude of the cardiacsignals, e.g., depolarizations, within the sensed cardiac EGM may varyover time, e.g., due to respiration. Such cardiac signal amplitudevariation may also be more prevalent in cardiac EGMs sensed usingcutaneous, subcutaneous, or extravascular electrodes. Variation incardiac signal amplitude may also cause depolarizations to temporarilyfall below a sensing threshold and, consequently, not be detected.

These types of improper sensing of depolarizations may lead to improperanalysis of the actual cardiac activity occurring with respect to thepatient being monitored. For example, these types of improper sensing ofdepolarizations may potentially trigger a false-positive indication of acardiac event, such as asystole, that is not actually occurring in thepatient. Such false-positive indications could lead to incorrectassessment of the patient condition, including provision of therapyand/or sending false alerts to medical personnel responsible for thecare of the patient being monitored. Low pass filtering of the cardiacEGM will generally not help solve these problems because these types ofnoise signals and amplitude variations may occur at frequencies near orbelow that of the cardiac signals.

Medical systems according to this disclosure implement techniques foridentifying false detection of asystole in cardiac EGMs by, for example,detecting the presence of noise signals and cardiac signal amplitudevariations. In some examples, processing circuitry of the systemsanalyzes a cardiac EGM associated with an identified asystole episode todetermine whether one or more of a plurality of false asystole detectioncriteria are satisfied. Each of the false asystole detection criteriamay be configured to detect one or more indicators of noise and/oramplitude variations in the cardiac EGM.

In some examples, processing circuity of a medical system performs thisanalysis in response to an asystole detection criterion being satisfied,and may determine whether to provide or withhold an indication (e.g., toa clinician or other user) that the patient experienced asystole basedon the analysis. The processing circuitry may perform the techniques ofthis disclosure substantially in real-time in response to the detectionof asystole, or during a later review of cardiac EGM data for episodesthat were identified as asystole. In either case, the processingcircuitry may include the processing circuitry of medical device thatdetected the asystole episode and/or processing circuitry of anotherdevice, such as a local or remote computing device which retrieved theepisode data from the medical device. In this manner, the techniques ofthis disclosure may advantageously enable improved accuracy in theidentification of true asystole and, consequently, better evaluation ofthe condition of the patient.

FIG. 1 illustrates the environment of an example medical system 2 inconjunction with a patient 4, in accordance with one or more techniquesof this disclosure. The example techniques may be used with an IMD 10,which may be in wireless communication with at least one of externaldevice 12 and other devices not pictured in FIG. 1. In some examples,IMD 10 is implanted outside of a thoracic cavity of patient 4 (e.g.,subcutaneously in the pectoral location illustrated in FIG. 1). IMD 10may be positioned near the sternum near or just below the level of theheart of patient 4, e.g., at least partially within the cardiacsilhouette. IMD 10 includes a plurality of electrodes (not shown in FIG.1), and is configured to sense a cardiac EGM via the plurality ofelectrodes. In some examples, IMD 10 takes the form of the LINQ™ ICM.

External device 12 may be a computing device with a display viewable bythe user and an interface for providing input to external device 12(i.e., a user input mechanism). In some examples, external device 12 maybe a notebook computer, tablet computer, workstation, one or moreservers, cellular phone, personal digital assistant, or anothercomputing device that may run an application that enables the computingdevice to interact with IMD 10.

External device 12 is configured to communicate with IMD 10 and,optionally, another computing device (not illustrated in FIG. 1), viawireless communication. External device 12, for example, may communicatevia near-field communication technologies (e.g., inductive coupling, NFCor other communication technologies operable at ranges less than 10-20cm) and far-field communication technologies (e.g., radiofrequency (RF)telemetry according to the 802.11 or Bluetooth® specification sets, orother communication technologies operable at ranges greater thannear-field communication technologies).

External device 12 may be used to configure operational parameters forIMD 10. External device 12 may be used to retrieve data from IMD 10. Theretrieved data may include values of physiological parameters measuredby IMD 10, indications of episodes of arrhythmia or other maladiesdetected by IMD 10, and physiological signals recorded by IMD 10. Forexample, external device 12 may retrieve cardiac EGM segments recordedby IMD 10 due to IMD 10 determining that an episode of asystole oranother malady occurred during the segment. As will be discussed ingreater detail below with respect to FIG. 5, one or more remotecomputing devices may interact with IMD 10 in a manner similar toexternal device 12, e.g., to program IMD 10 and/or retrieve data fromIMD 10, via a network.

Processing circuitry of medical system 2, e.g., of IMD 10, externaldevice 12, and/or of one or more other computing devices, may beconfigured to perform the example techniques for identifying falsedetection of asystole of this disclosure. In some examples, theprocessing circuitry of medical system 2 analyzes a cardiac EGM sensedby IMD 10 and associated with an identified asystole episode todetermine whether one or more of a plurality of false asystole detectioncriteria are satisfied. Each of the false asystole detection criteriamay be configured to detect one or more indicators of noise and/oramplitude variations in the cardiac EGM. Although described in thecontext of examples in which IMD 10 that senses the cardiac EGMcomprises an insertable cardiac monitor, example systems including oneor more implantable or external devices of any type configured to sensea cardiac EGM may be configured to implement the techniques of thisdisclosure.

FIG. 2 is a functional block diagram illustrating an exampleconfiguration of IMD 10 of FIG. 1 in accordance with one or moretechniques described herein. In the illustrated example, IMD 10 includeselectrodes 16A and 16B (collectively “electrodes 16”), antenna 26,processing circuitry 50, sensing circuitry 52, communication circuitry54, storage device 56, switching circuitry 58, and sensors 62. Althoughthe illustrated example includes two electrodes 16, IMDs including orcoupled to more than two electrodes 16 may implement the techniques ofthis disclosure in some examples.

Processing circuitry 50 may include fixed function circuitry and/orprogrammable processing circuitry. Processing circuitry 50 may includeany one or more of a microprocessor, a controller, a digital signalprocessor (DSP), an application specific integrated circuit (ASIC), afield-programmable gate array (FPGA), or equivalent discrete or analoglogic circuitry. In some examples, processing circuitry 50 may includemultiple components, such as any combination of one or moremicroprocessors, one or more controllers, one or more DSPs, one or moreASICs, or one or more FPGAs, as well as other discrete or integratedlogic circuitry. The functions attributed to processing circuitry 50herein may be embodied as software, firmware, hardware or anycombination thereof

Sensing circuitry 52 may be selectively coupled to electrodes 16 viaswitching circuitry 58, e.g., to select the electrodes 16 and polarity,referred to as the sensing vector, used to sense a cardiac EGM, ascontrolled by processing circuitry 50. Sensing circuitry 52 may sensesignals from electrodes 16, e.g., to produce a cardiac EGM, in order tofacilitate monitoring the electrical activity of the heart. Sensingcircuitry 52 also may monitor signals from sensors 62, which may includeone or more accelerometers, pressure sensors, and/or optical sensors, asexamples. In some examples, sensing circuitry 52 may include one or morefilters and amplifiers for filtering and amplifying signals receivedfrom electrodes 16 and/or sensors 62.

Sensing circuitry 52 and/or processing circuitry 50 may be configured todetect cardiac depolarizations (e.g., P-waves or R-waves) when thecardiac EGM amplitude crosses a sensing threshold. In some examples, thesensing threshold is automatically adjustable over time using any of avariety of automatic sensing threshold adjustment techniques known inthe art. For example, in response to detection of a cardiacdepolarization, the sensing threshold for detecting a subsequent cardiacdepolarization may decay from an initial value over a period of time.Sensing circuitry 52 and/or processing circuitry 50 may determine theinitial value based on the amplitude of detected cardiac depolarization.The initial value and decay of the adjustable sensing threshold may beconfigured such that the sensing threshold is relatively higher soonafter the detected cardiac depolarization when a subsequentdepolarization is not expected, and decays to relatively lower valuesover time as the occurrence of a cardiac depolarization becomes morelikely. For cardiac depolarization detection, sensing circuitry 52 mayinclude a rectifier, filter, amplifier, comparator, and/oranalog-to-digital converter, in some examples.

In some examples, sensing circuitry 52 may output an indication toprocessing circuitry 50 in response to sensing of a cardiacdepolarization. In this manner, processing circuitry 50 may receivedetected cardiac depolarization indicators corresponding to theoccurrence of detected R-waves and P-waves in the respective chambers ofheart. Processing circuitry 50 may use the indications of detectedR-waves and P-waves for determining heart rate and detectingarrhythmias, such as tachyarrhythmias and asystole.

Processing circuitry 50 may detect an asystole episode based ondetermining that the cardiac electrogram satisfies an asystole detectioncriterion. The asystole detection criterion may be absence of a cardiacdepolarization for a threshold period of time. In such examples,processing circuitry 50 may determine that the cardiac EGM satisfies theasystole detection criterion based on reaching a predetermined timeinterval from detection of a cardiac depolarization without receivinganother cardiac depolarization indication from sensing circuitry 52.

Sensing circuitry 52 may also provide one or more digitized cardiac EGMsignals to processing circuitry 50 for analysis, e.g., for use incardiac rhythm discrimination, and/or for analysis to determine whetherone or more false asystole detection criteria are satisfied according tothe techniques of this disclosure. In some examples, based onsatisfaction of the asystole detection criterion, processing circuitry50 may store a segment of the digitized cardiac EGM corresponding to thesuspected asystole as episode data in storage device 56. The digitizedcardiac EGM segment may include samples of the cardiac EGM spanning theperiod of time for which sensing circuitry 52 did not indicate detectionof a depolarization, as well as a period of time before and/or afterthis period of time during which depolarizations were detected.Processing circuitry 50 of IMD 10, and/or processing circuitry ofanother device that retrieves the episode data from IMD 10, may analyzethe cardiac EGM segment to determine whether one or more false asystoledetection criteria are satisfied according to the techniques of thisdisclosure.

Communication circuitry 54 may include any suitable hardware, firmware,software or any combination thereof for communicating with anotherdevice, such as external device 12, another networked computing device,or another IMD or sensor. Under the control of processing circuitry 50,communication circuitry 54 may receive downlink telemetry from, as wellas send uplink telemetry to external device 12 or another device withthe aid of an internal or external antenna, e.g., antenna 26. Inaddition, processing circuitry 50 may communicate with a networkedcomputing device via an external device (e.g., external device 12) and acomputer network, such as the Medtronic CareLink® Network. Antenna 26and communication circuitry 54 may be configured to transmit and/orreceive signals via inductive coupling, electromagnetic coupling, NearField Communication (NFC), Radio Frequency (RF) communication,Bluetooth, WiFi, or other proprietary or non-proprietary wirelesscommunication schemes.

In some examples, storage device 56 includes computer-readableinstructions that, when executed by processing circuitry 50, cause IMD10 and processing circuitry 50 to perform various functions attributedto IMD 10 and processing circuitry 50 herein. Storage device 56 mayinclude any volatile, non-volatile, magnetic, optical, or electricalmedia, such as a random access memory (RAM), read-only memory (ROM),non-volatile RAM (NVRAM), electrically-erasable programmable ROM(EEPROM), flash memory, or any other digital media. Storage device 56may store, as examples, programmed values for one or more operationalparameters of IMD 10 and/or data collected by IMD 10 for transmission toanother device using communication circuitry 54. Data stored by storagedevice 56 and transmitted by communication circuitry 54 to one or moreother devices may include episode data for suspected asystoles and/orindications that suspected asystoles satisfied one or more falseasystole detection criteria.

FIG. 3 is a conceptual side-view diagram illustrating an exampleconfiguration of IMD 10 of FIGS. 1 and 2. In the example shown in FIG.3, IMD 10 may include a leadless, subcutaneously-implantable monitoringdevice having a housing 15 and an insulative cover 76. Electrode 16A andelectrode 16B may be formed or placed on an outer surface of cover 76.Circuitries 50-62, described above with respect to FIG. 2, may be formedor placed on an inner surface of cover 76, or within housing 15. In theillustrated example, antenna 26 is formed or placed on the inner surfaceof cover 76, but may be formed or placed on the outer surface in someexamples. In some examples, insulative cover 76 may be positioned overan open housing 15 such that housing 15 and cover 76 enclose antenna 26and circuitries 50-62, and protect the antenna and circuitries fromfluids such as body fluids.

One or more of antenna 26 or circuitries 50-62 may be formed on theinner side of insulative cover 76, such as by using flip-chiptechnology. Insulative cover 76 may be flipped onto a housing 15. Whenflipped and placed onto housing 15, the components of IMD 10 formed onthe inner side of insulative cover 76 may be positioned in a gap 78defined by housing 15. Electrodes 16 may be electrically connected toswitching circuitry 58 through one or more vias (not shown) formedthrough insulative cover 76. Insulative cover 76 may be formed ofsapphire (i.e., corundum), glass, parylene, and/or any other suitableinsulating material. Housing 15 may be formed from titanium or any othersuitable material (e.g., a biocompatible material). Electrodes 16 may beformed from any of stainless steel, titanium, platinum, iridium, oralloys thereof. In addition, electrodes 16 may be coated with a materialsuch as titanium nitride or fractal titanium nitride, although othersuitable materials and coatings for such electrodes may be used.

FIG. 4 is a block diagram illustrating an example configuration ofcomponents of external device 12. In the example of FIG. 4, externaldevice 12 includes processing circuitry 80, communication circuitry 82,storage device 84, and user interface 86.

Processing circuitry 80 may include one or more processors that areconfigured to implement functionality and/or process instructions forexecution within external device 12. For example, processing circuitry80 may be capable of processing instructions stored in storage device84. Processing circuitry 80 may include, for example, microprocessors,DSPs, ASICs, FPGAs, or equivalent discrete or integrated logiccircuitry, or a combination of any of the foregoing devices orcircuitry. Accordingly, processing circuitry 80 may include any suitablestructure, whether in hardware, software, firmware, or any combinationthereof, to perform the functions ascribed herein to processingcircuitry 80.

Communication circuitry 82 may include any suitable hardware, firmware,software or any combination thereof for communicating with anotherdevice, such as IMD 10. Under the control of processing circuitry 80,communication circuitry 82 may receive downlink telemetry from, as wellas send uplink telemetry to, IMD 10, or another device. Communicationcircuitry 82 may be configured to transmit or receive signals viainductive coupling, electromagnetic coupling, NFC, RF communication,Bluetooth, WiFi, or other proprietary or non-proprietary wirelesscommunication schemes. Communication circuitry 82 may also be configuredto communicate with devices other than IMD 10 via any of a variety offorms of wired and/or wireless communication and/or network protocols.

Storage device 84 may be configured to store information within externaldevice 12 during operation. Storage device 84 may include acomputer-readable storage medium or computer-readable storage device. Insome examples, storage device 84 includes one or more of a short-termmemory or a long-term memory. Storage device 84 may include, forexample, RAM, DRAM, SRAM, magnetic discs, optical discs, flash memories,or forms of EPROM or EEPROM. In some examples, storage device 84 is usedto store data indicative of instructions for execution by processingcircuitry 80. Storage device 84 may be used by software or applicationsrunning on external device 12 to temporarily store information duringprogram execution.

Data exchanged between external device 12 and IMD 10 may includeoperational parameters. External device 12 may transmit data includingcomputer readable instructions which, when implemented by IMD 10, maycontrol IMD 10 to change one or more operational parameters and/orexport collected data. For example, processing circuitry 80 may transmitan instruction to IMD 10 which requests IMD 10 to export collected data(e.g., asystole episode data) to external device 12. In turn, externaldevice 12 may receive the collected data from IMD 10 and store thecollected data in storage device 84. Processing circuitry 80 mayimplement any of the techniques described herein to analyze cardiac EGMsreceived from IMD 10, e.g., to determine whether asystole and falseasystole criteria are satisfied.

A user, such as a clinician or patient 4, may interact with externaldevice 12 through user interface 86. User interface 86 includes adisplay (not shown), such as a liquid crystal display (LCD) or a lightemitting diode (LED) display or other type of screen, with whichprocessing circuitry 80 may present information related to IMD 10, e.g.,cardiac EGMs, indications of detections of arrhythmia episodes, andindications of determinations that one or more false asystole detectioncriteria were satisfied. In addition, user interface 86 may include aninput mechanism configured to receive input from the user. The inputmechanisms may include, for example, any one or more of buttons, akeypad (e.g., an alphanumeric keypad), a peripheral pointing device, atouch screen, or another input mechanism that allows the user tonavigate through user interfaces presented by processing circuitry 80 ofexternal device 12 and provide input. In other examples, user interface86 also includes audio circuitry for providing audible notifications,instructions or other sounds to the user, receiving voice commands fromthe user, or both.

FIG. 5 is a block diagram illustrating an example system that includesan access point 90, a network 92, external computing devices, such as aserver 94, and one or more other computing devices 100A-100N(collectively, “computing devices 100”), which may be coupled to IMD 10and external device 12 via network 92, in accordance with one or moretechniques described herein. In this example, IMD 10 may usecommunication circuitry 54 to communicate with external device 12 via afirst wireless connection, and to communicate with an access point 90via a second wireless connection. In the example of FIG. 5, access point90, external device 12, server 94, and computing devices 100 areinterconnected and may communicate with each other through network 92.

Access point 90 may include a device that connects to network 92 via anyof a variety of connections, such as telephone dial-up, digitalsubscriber line (DSL), or cable modem connections. In other examples,access point 90 may be coupled to network 92 through different forms ofconnections, including wired or wireless connections. In some examples,access point 90 may be a user device, such as a tablet or smartphone,that may be co-located with the patient. IMD 10 may be configured totransmit data, such as asystole episode data and indications that one ormore false asystole detection criteria are satisfied, to access point90. Access point 90 may then communicate the retrieved data to server 94via network 92.

In some cases, server 94 may be configured to provide a secure storagesite for data that has been collected from IMD 10 and/or external device12. In some cases, server 94 may assemble data in web pages or otherdocuments for viewing by trained professionals, such as clinicians, viacomputing devices 100. One or more aspects of the illustrated system ofFIG. 5 may be implemented with general network technology andfunctionality, which may be similar to that provided by the MedtronicCareLink® Network.

In some examples, one or more of computing devices 100 may be a tabletor other smart device located with a clinician, by which the clinicianmay program, receive alerts from, and/or interrogate IMD 10. Forexample, the clinician may access data collected by IMD 10 through acomputing device 100, such as when patient 4 is in in between clinicianvisits, to check on a status of a medical condition. In some examples,the clinician may enter instructions for a medical intervention forpatient 4 into an application executed by computing device 100, such asbased on a status of a patient condition determined by IMD 10, externaldevice 12, server 94, or any combination thereof, or based on otherpatient data known to the clinician. Device 100 then may transmit theinstructions for medical intervention to another of computing devices100 located with patient 4 or a caregiver of patient 4. For example,such instructions for medical intervention may include an instruction tochange a drug dosage, timing, or selection, to schedule a visit with theclinician, or to seek medical attention. In further examples, acomputing device 100 may generate an alert to patient 4 based on astatus of a medical condition of patient 4, which may enable patient 4proactively to seek medical attention prior to receiving instructionsfor a medical intervention. In this manner, patient 4 may be empoweredto take action, as needed, to address his or her medical status, whichmay help improve clinical outcomes for patient 4.

In the example illustrated by FIG. 5, server 94 includes a storagedevice 96, e.g., to store data retrieved from IMD 10, and processingcircuitry 98. Although not illustrated in FIG. 5 computing devices 100may similarly include a storage device and processing circuitry.Processing circuitry 98 may include one or more processors that areconfigured to implement functionality and/or process instructions forexecution within server 94. For example, processing circuitry 98 may becapable of processing instructions stored in storage device 96.Processing circuitry 98 may include, for example, microprocessors, DSPs,ASICs, FPGAs, or equivalent discrete or integrated logic circuitry, or acombination of any of the foregoing devices or circuitry. Accordingly,processing circuitry 98 may include any suitable structure, whether inhardware, software, firmware, or any combination thereof, to perform thefunctions ascribed herein to processing circuitry 98. Processingcircuitry 98 of server 94 and/or the processing circuity of computingdevices 100 may implement any of the techniques described herein toanalyze cardiac EGMs received from IMD 10, e.g., to determine whetherasystole and false asystole criteria are satisfied.

Storage device 96 may include a computer-readable storage medium orcomputer-readable storage device. In some examples, storage device 96includes one or more of a short-term memory or a long-term memory.Storage device 96 may include, for example, RAM, DRAM, SRAM, magneticdiscs, optical discs, flash memories, or forms of EPROM or EEPROM. Insome examples, storage device 96 is used to store data indicative ofinstructions for execution by processing circuitry 98.

FIG. 6 is a flow diagram illustrating an example operation fordetermining whether an identification of an asystole episode was falsebased on whether a plurality of false asystole detection criteria issatisfied. According to the illustrated example of FIG. 6, processingcircuitry 50 of IMD 10 determines that at least one asystole detectioncriterion is satisfied based on a cardiac EGM sensed by sensingcircuitry 52 of IMD 10 (120). For example, as discussed in greaterdetail with respect to FIG. 2, processing circuitry 50 may determinethat a threshold time interval, e.g., 2-3 seconds, has passed sincesensing circuitry 52 identified a cardiac depolarization, e.g., R-wave,within the cardiac EGM.

Based on determining that the asystole detection criterion is satisfied,processing circuitry 50 determines whether the one or more of aplurality of false asystole detection criteria are satisfied. In theillustrated example, processing circuitry 50 determines whether a falseasystole detection criterion comprising an asystole detection countcriterion is satisfied (122). For example, processing circuitry 50 maydetermine whether the asystole detection criterion was satisfied atleast a threshold number of times within a predetermined time periodextending back from the most recent satisfaction of the asystoledetection criterion, e.g., at least two times within the past thirtydays. As another example, processing circuitry may determine whether theasystole detection criterion was satisfied at a threshold rate, e.g., arate of one asystole per thirty days, over a time period. The timeperiod may be the entire time IMD 10 has been active since implant, orsince a period start time other than implant, e.g., a period starting afixed number of days, weeks, or months after implant, or upon a power onreset or other reset of IMD 10.

Based on determining that the asystole detection count criterion is notsatisfied (NO of 122), the example operation of FIG. 6 ends (124). Basedon determining that the asystole detection count criterion is satisfied(YES of 122), processing circuitry 50 proceeds to determine whether oneor more of the other false asystole detection criteria are satisfied.Implementation of such an asystole detection count criterion is based onan observation that false detection of asystole tends to occur indevices that frequently detect asystole, and to not occur in devicesthat infrequently detect asystole. Requiring satisfaction for theasystole detection count criterion prior to applying the other falseasystole detection criteria, as in the example operation of FIG. 6, mayavoid erroneous classification of a suspect asystole as false by thefalse asystole detection criteria.

Noise signals may occur in the cardiac EGM intermittently or withvarying frequency based on, for example, changes in the condition of IMD10 or patient 4. Consequently, there may be a greater likelihood that agiven asystole detection is false (e.g., caused by noise) during aperiod in which asystole detection is more frequent (indicating thatthere may be noise in the EGM) than a period in which asystole detectionis less frequent. Implementing an asystole detection count criterion toselectively activate and deactivate evaluation of the cardiac EGM ofsuspected asystole episodes using the false asystole detection criteriadescribed herein may achieve varying emphasis on sensitivity versusspecificity for asystole detection depending on the recent frequency ofasystole and, thus, the likelihood that most recent asystole episode isfalse.

During periods in which asystole frequency is below a threshold suchthat the asystole count criterion is not satisfied, processing circuitry50 may not activate evaluation of the cardiac EGMs of suspected asystoleepisodes using the false asystole detection criteria, thereby preservingsensitivity of the asystole detection. During periods in which asystolefrequency is above a threshold such that the asystole count criterion isnot satisfied, processing circuitry 50 may activate evaluation of thecardiac EGMs of suspected asystole episodes using the false asystoledetection criteria, thereby improving specificity of the asystoledetection. Selectively (e.g., intermittently) activating anddeactivating evaluation of the cardiac EGMs of suspected asystoleepisodes using the false asystole detection criteria may thus provide adesired balance between sensitivity and specificity for the currentcondition of the cardiac EGM, e.g., degree of noise in the cardiac EGM.

In the illustrated example, based on determining that the asystoledetection count criterion is satisfied (YES of 122), processingcircuitry 50 proceeds to determine whether, using a reduced amplitudethreshold, a threshold number of depolarizations are detected within thetime interval of the cardiac EGM for which depolarizations were notdetected using the asystole detection criteria amplitude threshold(126). Based on the depolarizations at reduced amplitude thresholdcriterion being satisfied (YES of 126), processing circuitry 50 maydetermine that the suspected asystole episode is a false asystole (128).Based on the depolarizations at reduced amplitude threshold criterionnot being satisfied (NO of 126), processing circuitry 50 may proceed toconsider another false asystole detection criterion.

In the illustrated example, based on determining that thedepolarizations at reduced amplitude threshold criterion is notsatisfied (NO of 126), processing circuitry 50 proceeds to determinewhether the cardiac EGM associated with the asystole detection criterionbeing satisfied also satisfies a decaying noise criterion (130). Basedon the decaying noise criterion being satisfied (YES of 130), processingcircuitry 50 may determine that the suspected asystole episode is afalse asystole (128). Based on the decaying noise criterion not beingsatisfied (NO of 130), processing circuitry 50 may proceed to consideranother false asystole detection criterion.

In the illustrated example, based on determining that the decaying noisecriterion is not satisfied (NO of 130), processing circuitry 50 proceedsto determine whether the cardiac EGM associated with the suspectedasystole episode satisfies a preceding depolarization variabilitycriterion (132). Based on the preceding depolarization variabilitycriterion being satisfied (YES of 132), processing circuitry 50 maydetermine that the suspected asystole episode is a false asystole (128).Based on the preceding depolarization variability criterion not beingsatisfied (NO of 132), processing circuitry 50 may proceed to consideranother false asystole detection criterion.

In the illustrated example, based on determining that the precedingdepolarization variability criterion is not satisfied (NO of 132),processing circuitry 50 proceeds to determine whether the cardiac EGMassociated with the suspected asystole episode satisfies an energypattern criterion (134). Based on the energy pattern criterion beingsatisfied (YES of 134), processing circuitry 50 may determine that thesuspected asystole episode is a false asystole (128). Based on theenergy criterion not being satisfied (NO of 134), the example operationof FIG. 6 ends (124).

Based on the example operation of FIG. 6 ending (124), e.g., due to noneof the false asystole detection criteria being satisfied, or aninsufficient number or combination of the false asystole detectioncriteria being satisfied, processing circuitry 50 may classify thesuspected asystole episode as a true asystole episode. Based on theasystole episode being classified as true, processing circuitry 50 mayuse the asystole episode in further operations, such as calculatingstatistics, determining a condition of patient, or transmitting trueepisode data to other devices. Based on determining that the suspectedasystole episode is a false asystole (128), processing circuitry 50 mayuse the false asystole episode in further operations, such ascalculating statistics of false episodes and transmitting false episodedata to other devices, e.g., for consideration by a user of amodification of the operation of IMD 10 to avoid further false asystoledetection.

The order and flow of the operation illustrated in FIG. 6 is oneexample. In other examples according to this disclosure, more or fewerfalse asystole detection criteria may be considered, the false asystoledetection criteria may be considered in a different order, orsatisfaction of different numbers or combinations of false asystoledetection criteria may be required for a determination that thesuspected asystole episode was false. Further, in some examples,processing circuitry may perform or not perform the method of FIG. 6, orany of the techniques described herein, as directed by a user, e.g., viaexternal device 12 or computing devices 100. For example, a patient,clinician, or other user may turn on or off functionality foridentifying false asystole detection remotely (e.g., using Wi-Fi orcellular services) or locally (e.g., using an application provided on apatient's cellular phone or using a medical device programmer).

Additionally, although described in the context of an example in whichIMD 10, and processing circuitry 50 of IMD 10, perform each of theportions of the example operation, the example operation of FIG. 6, aswell as the example operations described herein with respect to FIGS.7-17, may be performed by any processing circuitry of any one or moredevices of a medical system, e.g., any combination of one or more ofprocessing circuitry 50 of 1MB 10, processing circuitry 80 of externaldevice 12, processing circuitry 98 of server 94, or processing circuitryof computing devices 100. In some examples, processing circuitry 50 of1MB 10 may determine whether an asystole detection criterion issatisfied, and provide episode data for the suspected asystole episodesto another device. In such examples, processing circuitry of the otherdevice, e.g., external device 12, server 94, or a computing device 100,may apply one or more false asystole detection criteria to the episodedata.

FIG. 7 is a graph illustrating a cardiac EGM 148 associated with anidentified episode suspected to be asystole, and an example techniquefor determining whether an example false asystole detection criterion issatisfied based on cardiac EGM 148. In some examples, cardiac EGM 148 isa digitized segment of a cardiac EGM sensed by sensing circuitry 52 ofIMD 10 via electrodes 16, and corresponds to a suspected asystoleepisode identified by processing circuitry 50 applying one or moreasystole detection criteria to the cardiac EGM.

FIG. 7 illustrates cardiac depolarizations 150A-150H (in this exampleR-waves) identified by IMD 10, e.g., by comparing cardiac EGM 148 to anamplitude threshold, which may be automatically adjustable, as describedherein. FIG. 7 also illustrates an asystole interval 152. Asystoleinterval 152 represents an interval of time between adjacentdepolarizations 150F and 150G identified by IMD 10. As described herein,processing circuitry 50 may have determined that an asystole detectioncriterion was satisfied when asystole interval 152 reached apredetermined threshold amount of time. Based on the satisfaction of theasystole detection criterion, processing circuitry 50 may have storedcardiac EGM 148, including time periods before and after asystoleinterval 152, and indications of the detections (e.g., the timing) ofdepolarizations 150A-150H in storage device 52.

As described with reference to item 126 of FIG. 6, one false asystoledetection criterion may include determining whether, using a reducedamplitude threshold 154, a threshold number of depolarizations aredetected within cardiac EGM 148 during asystole interval 152. In theexample illustrated by FIG. 7, processing circuitry 50 detectsdepolarizations 1501-150K during interval 152 by comparing cardiac EGM148 to reduced amplitude threshold 154. The threshold number ofdepolarizations detected during interval 152 using threshold 154 neededto satisfy the reduced amplitude threshold criterion may be any integergreater than or equal to one, including two or three detecteddepolarizations.

In some examples, processing circuitry 50 determines reduced amplitudethreshold 154 based on amplitudes of a predetermined number ofdepolarizations 150A-150F that precede asystole interval 152. In someexamples, processing circuitry 50 determines the amplitudes ofdepolarizations 150A-150F by determining amplitudes of cardiac EGM 148at samples corresponding to zero-crossings in a differential signal ofcardiac EGM 148. In some examples, processing circuitry 50 determines arepresentative value of the amplitudes of depolarizations 150A-150F,e.g., a median or mean of the amplitudes, and determines reducedamplitude threshold 154 to be a predetermined portion, e.g., fraction orpercentage, of the representative amplitude. As examples thepredetermined portion may be 1/10, ⅛, ⅕, ⅓, or ½. Any number ofpreceding depolarizations may be used to determine threshold 154, suchas two to eight preceding depolarizations, including six precedingdepolarizations in some examples.

In one example, if the median amplitude of six preceding R-waves is 80microvolts (μV), the reduced amplitude threshold 154 of ⅛^(th) of themedian amplitude would be 10 μV. In such an example, processingcircuitry 50 would determine the false asystole detection criterion wassatisfied if there are 15 μV signals in cardiac EGM 148 during interval152. Applying reduced amplitude threshold 154 during asystole interval152 may also obscure AV blocks with P-waves of 15 μV. However,application of this false asystole detection criterion based onsatisfaction of an asystole detection count criterion (122 of FIG. 6),and the low probability that this false asystole detection criterionwill be satisfied in by cardiac EGMs with relatively high R-waveamplitudes, reduces the likelihood of incorrect classification of theepisode.

FIG. 8 is a flow diagram illustrating an example operation fordetermining whether an example false asystole criterion that includes areduced amplitude threshold for depolarization detection is satisfied,e.g., corresponding to item 126 in FIG. 6. The example operation of FIG.8 is described with reference to the cardiac EGM 148 and other dataillustrated in FIG. 7.

According to the illustrated example of FIG. 8, processing circuitry 50of IMD 10 identifies a predetermined number “N” of the depolarizations150 preceding an asystole interval 152, e.g., the most recent Ndepolarizations before the asystole interval (160). Processing circuitry50 determines the amplitudes of the N preceding depolarizations 150(162). Processing circuitry 50 determines a reduced amplitude threshold154 based on the amplitudes of the N preceding depolarizations 150,e.g., based on a predetermined fraction or other portion of a median orother representative value of the determined amplitudes of the Npreceding depolarizations 150 (164).

Processing circuitry 50 compares the reduced amplitude threshold 154 tothe cardiac EGM 148 within asystole interval 152, e.g., the portion ofcardiac EGM 148 within the entire asystole interval or within a portionof the asystole interval (166). Processing circuitry 50 determineswhether a threshold number of depolarizations 150 are identified withinasystole interval 152 based on the comparison, e.g., based on cardiacEGM 148 being equal to or greater than reduced amplitude threshold 154within the asystole interval (168). As examples, the threshold number ofdepolarizations may be one, two, or three depolarizations. Based ondetecting the threshold number of depolarizations (YES of 168),processing circuitry 50 may determine that the suspected asystoleepisode is a false asystole (128). Based on not detecting the thresholdnumber of depolarizations (NO of 168), processing circuitry 50 mayproceed to application of another false asystole detection criterion,such as a decaying noise criterion described with reference to block 130of FIG. 6 (170).

FIG. 9 is a graph illustrating a cardiac EGM 181 that includes decayingnoise. Cardiac EGM 181 may be a digitized cardiac EGM segment includedas episode data for a suspected asystole episode.

Over the time span generally indicated by bracket 182, cardiac EGM 181includes a somewhat consistent pattern of peaks and variations inamplitude that is repeated at a relatively consistent interval in time.During the time span generally indicated by bracket 183, cardiac EGM 181does not continue to provide the consistent pattern previously providedduring the time span indicated by bracket 182, but instead provides alarge amplitude spike 184 having an amplitude and a duration that ismuch larger than any of the peaks provided in cardiac EGM 181 during thetime span indicated by bracket 182.

Following the amplitude spike 184, and during the time span generallyindicated by bracket 185, cardiac EGM 181 includes a larger variation inthe amplitude of the signal, and may include more negative peaks and/ora lower overall average or median amplitude value compared to these sameparameters if measured over the time span indicated by bracket 182. Insome examples of a false asystole detection criterion, processingcircuitry 50 may analyze amplitude spike 184 and/or the variationsillustrated during the time span indicated by bracket 185 following theamplitude spike 184 to determine if these portions of cardiac EGM 181are representative of a noise signal, e.g., decaying noise.

FIG. 10 is a graph illustrating a cardiac EGM 191 that includes decayingnoise and an example technique for determining whether an example falseasystole detection criterion is satisfied based on the cardiac EGM.Cardiac EGM 191 may be a digitized cardiac EGM segment included by IMD10 as episode data for a suspected asystole episode, e.g., based onprocessing circuity 50 of IMD 10 determining that an asystole detectioncriterion was satisfied.

As shown in FIG. 10, cardiac EGM 191 includes an amplitude spike 202 inthe portion of cardiac EGM 191 following the time indicated as “0”(zero) seconds. Using a set of detection windows, for example asillustratively represented by detection windows 194 and 196 in theexample of FIG. 10, processing circuitry 50 may analyze one or moreportions of cardiac EGM 191 to determine if cardiac EGM 191 includes anoise signal, such as the amplitude spike 202 or other decaying noise.

In various examples, analyzing cardiac EGM 191 to determine if a noisesignal is present includes determining a sample time 192 as a basis forsetting detection windows 194 and 196. In some examples, determiningsample time 192 comprises setting the sample time equal to a time wherea depolarization 203, e.g., R-wave, has been detected within cardiac EGM191. Depolarization 203 may be a most recent depolarization preceding anasystole interval 152 (FIG. 7), in some examples.

Once processing circuitry 50 selects a sample time 192, processingcircuitry 50 may set a baseline window 194 so that the baseline windowincludes a time span 195 extending from sample time 192 and for someamount of time prior to sample time 192. The width of time span 195 isnot limited to any particular time span, and in some examples may be atime span in a range of 0.5 to 5 seconds. In the example of FIG. 10,baseline window 194 extends from sample time 192 and comprises anillustrative time span 195 of approximately 1 second, extending toinclude the portion of cardiac EGM 191 ranging from sample time 192 to atime up to one second prior to sample time 192.

In various examples, processing circuitry 50 determines a baselineamplitude value 199 based on sample time 192 and baseline window 194.Processing circuitry 50 may calculate the value for baseline amplitude199 by determining the amplitudes of samples of cardiac EGM 191 thatfall within baseline window 194, and determining baseline amplitude 199based on these determined amplitude values. In some examples, the valuefor baseline amplitude 199 may be a mean or median of the amplitudevalues of cardiac EGM 191 during baseline window 194.

Processing circuitry 50 also sets a measurement window 196 to include atime span 197 extending from sample time 192 and for some amount of timefollowing sample time 192. Time span 197 is not limited to anyparticular duration, and in some examples may be in a range of 0.5 to 5seconds. In the example of FIG. 10, time span is approximately 1 secondin duration, including the portion of cardiac EGM 191 ranging fromsample time 192 to a time up to one second subsequent to sample time192. In various examples, the width of time span 197 for the measurementwindow 196 is equal to or different then the width of time span 195 setfor the baseline window 194. In examples in which depolarization 203 isa most recent depolarization preceding an asystole interval 152,measurement window 196 includes at least a portion of the asystoleinterval.

Processing circuitry 50 may determine amplitude values of samples ofcardiac EGM 191 within measurement window 196. Processing circuitry 50may determine an area-under-the-curve value for the portion of cardiacEGM 191 based on these sampled amplitude values within measurementwindow 196 and baseline amplitude value 199 determined based on baselinewindow 194.

For example, processing circuitry 50 may determine a set of differencevalues between the amplitude values of cardiac EGM 191 falling withinthe measurement window 196 and baseline amplitude value 199. In someexamples, processing circuitry 50 determines an area-under-the-curvevalue by calculating an area 198 that is included below a portion ofcardiac EGM 191 that falls within measurement window 196 and is abovebaseline amplitude value 199. Calculation of the area-under-the-curvevalue is not limited to any particular technique for calculating thisarea, and may include any technique for calculating an area under acurve, as would be understood by one of ordinary skill in the art. Oncean area-under-the-curve value has been calculated for area 198,processing circuitry 50 may compare the area-under-the-curve value to anoise signal threshold value. In some examples, if thearea-under-the-curve value exceeds or is equal to the noise signalthreshold value, processing circuitry 50 determines that a noise signalhas been detected within cardiac EGM 191 and that a false asystoledetection criterion is satisfied.

Although baseline window 194 extends back in time and measurement window196 extends forward in time from the most recent precedingdepolarization 203 in the example of FIG. 10, processing circuitry 50may set baseline window 194 and measurement window 196 with other timerelationships to depolarization 203. For example, processing circuitry50 may set baseline window 194 to extend forward in time fromdepolarization 203, and measurement window 196 to extend forward in timefrom an end of baseline window 194. In such examples, baseline window194 may correspond to a period after detection of depolarization 203during which IMD 10 is prevented from detecting subsequentdepolarizations, referred to as a blanking period. In such examples,measurement window 196 may have a greater duration than baseline window194, e.g., to capture an expected duration of amplitude spike 202. Insome examples, baseline window 194 and measurement window 196 need notbe consecutive or contiguous.

Generally, P-waves are relatively narrower and/or more evenlydistributed above and below the baseline amplitude, and therefore havesmaller area-under-the-curve measurements, then decaying, e.g.,exponentially decaying, noise signals. Consequently,area-under-the-curve measurement may be an effective discriminatorbetween P-waves occurring during true asystole and decaying noise thatresulted in false asystole detection.

FIG. 11 is a flow diagram illustrating an example operation fordetermining whether an example false asystole criterion for detectingdecaying noise is satisfied, e.g., corresponding to item 130 in FIG. 6.The example operation of FIG. 11 is described with reference to thecardiac EGM 148 and other data illustrated in FIG. 7, and cardiac EGM191 and other data illustrated in FIG. 10.

According to the example of FIG. 11, processing circuitry 50 identifiesa last depolarization 203 preceding an asystole interval 152 (220).Processing circuitry 50 further sets baseline window 194 and measurementwindow 196 based on the time of last depolarization 203 (222).Processing circuitry 50 determines baseline amplitude 199 based onamplitudes of cardiac EGM 191 within baseline window 194, e.g., as amean or median of the amplitudes within baseline window 194 (224).

Processing circuitry 50 further determines an area-under-the-curvemeasurement for the portion of cardiac EGM 191 within measurement window196 relative to baseline amplitude 199 (226). For example, processingcircuitry 50 may determine the area-under-the curve measurement based ona sum of the differences between the amplitudes of samples of cardiacEGM 191 within measurement window 196 and the baseline amplitude 199.Any known techniques for area-under-the-curve measurement may beemployed.

Processing circuitry 50 determines whether the area-under-the-curvemeasurement satisfies a threshold, e.g., equal to or greater than thethreshold (228). Based on the area-under-the-curve measurementsatisfying the threshold (YES of 228), processing circuitry 50 maydetermine that the suspected asystole episode is a false asystole (128).Based on the area-under-the-curve measurement not satisfying threshold(NO of 228), processing circuitry 50 may proceed to application ofanother false asystole detection criterion, such as a precedingdepolarization variability criterion as described with reference toblock 132 of FIG. 6 (170).

FIG. 12 is a graph illustrating a differential signal 241 of a cardiacEGM that includes decaying noise and an example technique fordetermining whether an example false asystole detection criterion issatisfied based on the cardiac EGM. Processing circuitry 50 of IMD 10may determine differential signal 241 based on a digitized cardiac EGMsegment included by IMD 10 as episode data for a suspected asystoleepisode, e.g., based on processing circuity 50 determining that anasystole detection criterion was satisfied. In some examples, processingcircuitry 50 determines the value of each sample “y” of differentialsignal 241 by taking an amplitude value for the corresponding sample “y”of the cardiac EGM, and subtracting from that amplitude value theamplitude value of the cardiac EGM at sample “y-n”, wherein n is apredetermined number of samples.

As shown in FIG. 12, some of the values of differential signal 241 fallbelow a “zero” value line 237, and some of the signal values withindifferential signal 241 fall above the “zero” value line 237. A noisesignal in the cardiac EGM, such as the amplitude spike 202 asillustrated in FIG. 10, may result in a differential signal having oneor more spikes, such as spikes 242 in differential signal 241, followedby a gradual return of differential signal 241 to zero value line 237.

Processing circuitry 50 may set a measurement window 246 based on thedetection of an event, such as an R-wave of other depolarization 243 inthe cardiac EGM. In the illustrated example, a time span 245 begins atthe time of detection of depolarization 243. In the example of FIG. 12,time span 245 extends for a time period of 0.5 seconds. The time periodincluded within time span 245 is not limited to any particular timespan, and may range from 0.2 to 1 second in some examples. In someexamples, time span 245 may correspond to a period after detection ofdepolarization 243 during which IMD 10 is prevented from detectingsubsequent depolarizations, referred to as a blanking period.

Measurement window 246 begins at the time of expiration of time span245, illustrated by vertical dashed line 247, and extends over time span248, ending at the expiration of time span 248. In the example of FIG.12, time span 248 extends for a time period of 1.5 seconds. The timeperiod included in time span 248 is not limited to any particular timespan, and may range from one to five seconds in some examples.

Processing circuitry 50 determines a sign, i.e., positive above zeroline 237, negative below zero line 237, or on the zero line for thesamples of differential signal 241 within measurement window 246.Processing circuitry 50 determines a count of one or more of the signs,and determines whether the count satisfies, e.g., equals, exceeds, or isbelow, a threshold. The count may take the form of a percentage orfraction of the total number of samples considered. In general, whendecaying noise is present in the cardiac EGM, the signs of differentialsignal 241 within measurement window 246 will be unbalanced, e.g., moresigns are negative in the example of FIG. 12. Although negative signsmay be counted or quantified in some examples, other examples mayinclude counting or quantifying a number of positive sample values, anumber of non-negative sample values (e.g., a count of zero samplevalues plus positive sample values) or a number of non-positive samplevalues (e.g., a count of zero sample values plus negative samplevalues).

Using an imbalance of the signs of a differential signal within ameasurement window following last depolarization to detect the presenceof decaying noise may involve easier calculations for processingcircuitry 50 of IMD 10 then calculating an area-under-the-curve todetect the decaying noise. Further, P-waves or thermal noise occurringduring an asystole interval during a true asystole will have asubstantially equal distribution of signs of the differential signalwithin the measurement window (occurring during the asystole interval)while exponential or other decaying noise may have more than 70% ofsamples with a comment, e.g., negative, sign.

FIG. 13 is a flow diagram illustrating another example operation fordetermining whether an example false asystole criterion for detectingdecaying noise is satisfied. The example operation of FIG. 13 isdescribed with reference to the cardiac differential signal 241 andother data illustrated in FIG. 12.

According to the example of FIG. 13, processing circuitry 50 identifiesa last depolarization 243 preceding an asystole interval, e.g., asystoleinterval 152 in FIG. 7 (260). Processing circuitry further sets ameasurement window 246 that begins a time period 245 after the lastdepolarization (262), and determines a differential signal 241 withinthe measurement window 246 (264). Processing circuitry 50 furtherdetermines the signs of samples of differential signal 241 withinmeasurement window 246 and, for at least one of the signs, counts orotherwise quantifies the number of samples having the sign (266).

Processing circuitry 50 determines whether the count of one of the signssatisfies a common sign threshold, e.g., is equal to or greater than thethreshold (268). Based on the common sign threshold being satisfied (YESof 268), processing circuitry 50 may determine that the suspectedasystole episode is a false asystole (128). Based on the common signthreshold not being satisfied (NO of 268), processing circuitry 50 mayproceed to application of another false asystole detection criterion,such as a preceding depolarization variability criterion as describedwith reference to block 132 of FIG. 6 (270).

FIG. 14 is a graph illustrating a cardiac EGM 290 associated with anidentified asystole episode and an example technique for determiningwhether another example false asystole detection criterion is satisfiedbased on the cardiac EGM. Cardiac EGM 290 may be a digitized cardiac EGMsegment included by IMD 10 as episode data for a suspected asystoleepisode, e.g., based on processing circuity 50 of IMD 10 determiningthat an asystole detection criterion was satisfied.

FIG. 14 illustrates cardiac depolarizations 292A-292G (in this exampleR-waves) identified by IMD 10, e.g., by comparing cardiac EGM 290 to anamplitude threshold, which may be automatically adjustable, as describedherein. FIG. 14 also illustrates an asystole interval 294. Asystoleinterval 294 represents an interval of time between adjacent (in time)depolarizations 292F and 292G identified by IMD 10. As described herein,processing circuitry 50 may have determined that an asystole detectioncriterion was satisfied when asystole interval 294 reached apredetermined threshold amount of time. Based on the satisfaction of theasystole detection criterion, processing circuitry may have storedcardiac EGM 290, including time periods before and after asystoleinterval 294, and indications of the detections (e.g., the timing) ofdepolarizations 292A-292G (collectively, “depolarizations 292”) instorage device 52.

As described with reference to item 132 of FIG. 6, one false asystoledetection criterion may include determining whether a variability of Ndepolarizations 292 preceding asystole interval 294 satisfies avariability threshold. The number “N” of depolarizations precedingasystole interval 294 may be any integer greater than one, such as four,six, or eight. The N depolarizations 292 may, but need not, include thelast depolarization 292F preceding asystole interval 294. For example,processing circuitry 50 may determine a variability of the sixdepolarizations 292A-292F preceding asystole interval 292.

The variability may be of amplitudes or other characteristics of thedepolarizations 292. Processing circuitry 50 may use any known techniquefor measuring or otherwise characterizing the variability of a pluralityof values in order to determine the variability of the precedingdepolarizations 292. In some examples, processing circuitry 50 compares,e.g., determines a difference between, a maximum amplitude and a medianamplitude of the preceding depolarizations. In such examples, processingcircuitry 50 may determine whether the difference or other comparisonsatisfies, e.g., exceeds, a predetermined threshold.

Electrical noise can cause false asystole detection. In some examples,the cardiac EGM for an asystole episode falsely detected due toelectrical noise looks like a flat line added with random peaks rangingfrom 40 uV to 2000 uV. A true cardiac EGM would likely not include sucha wide range in R-wave amplitudes in few seconds. Variability ofpreceding depolarizations, e.g., difference between the maximum andmedian, may be very sensitive and specific to false asystole detectioncaused by electric noise. Although such a criterion might wrongly rejecta true asystole detection if electrical noise happens to occur justprior to a true asystole detection, this confluence is unlikely tooccur, particularly in IMDs with asystole detection frequencies below anasystole count detection threshold (122 of FIG. 6).

FIG. 15 is a flow diagram illustrating another example operation fordetermining whether an example false asystole criterion is satisfied.The example operation of FIG. 15 is described with reference to thecardiac EGM 290 and other data illustrated in FIG. 14.

According to the example of FIG. 15, processing circuitry 50 identifiesN depolarizations 292 preceding asystole interval 294 (300). Processingcircuitry 50 determines a variability of the N preceding depolarizations292. For example, processing circuitry 50 may determine amplitudes ofthe N preceding depolarizations 292, determine a maximum amplitude ofthe N preceding depolarizations 292, and determine a representativevalue of the amplitudes of the N preceding depolarizations 292, e.g., amedian or mean of the amplitudes (302). Processing circuitry 50 furtherdetermines a metric of comparison between the maximum amplitude and therepresentative amplitude, such as a difference or ratio (304).

Processing circuitry 50 determines whether the metric of comparisonsatisfies the threshold, e.g., is equal to or greater than the threshold(306). Based on the metric of comparison satisfying the threshold (YESof 306), processing circuitry 50 may determine that the suspectedasystole episode is a false asystole (128). Based on the metric ofcomparison not satisfying the threshold (NO of 306), processingcircuitry 50 may proceed to application of another false asystoledetection criterion, such as an energy pattern criterion as describedwith reference to block 134 of FIG. 6 (308).

FIG. 16 is a graph illustrating a cardiac EGM 320 associated with anidentified asystole episode and an example technique for determiningwhether another example false asystole detection criterion is satisfiedbased on the cardiac EGM. Cardiac EGM 320 may be a digitized cardiac EGMsegment included by IMD 10 as episode data for a suspected asystoleepisode, e.g., based on processing circuity 50 of IMD 10 determiningthat an asystole detection criterion was satisfied.

FIG. 16 illustrates cardiac depolarizations 322A-322E (in this exampleR-waves) identified by IMD 10, e.g., by comparing cardiac EGM 320 to anamplitude threshold, which may be automatically adjustable, as describedherein. FIG. 16 also illustrates an asystole interval 323. Asystoleinterval 323 represents an interval of time between adjacentdepolarizations 322D and 322E identified by IMD 10. As described herein,processing circuitry 50 may have determined that an asystole detectioncriterion was satisfied when asystole interval 323 reached apredetermined threshold amount of time. Based on the satisfaction of theasystole detection criterion, processing circuitry 50 may have storedcardiac EGM 320, including time periods before and after asystoleinterval 323, and indications of the detections (e.g., the timing) ofdepolarizations 322A-322E (collectively, “depolarizations 322”) instorage device 52.

As described with reference to item 134 of FIG. 6, one false asystoledetection criterion may include evaluating an energy pattern of cardiacEGM 320 during asystole interval 323. When a physician reviews agraphical representation of a cardiac EGM, such as cardiac EGM 320, todetermine whether a suspected asystole is true or false, the physicianmay measure or estimates R-R intervals before asystole interval 323, anddetermine whether there are visible small peaks within asystole interval323 that are in the same pace or in phase with, e.g., that would havesimilar R-R intervals to, the preceding R-R intervals. Such a patternmay indicate to the physician that the asystole detection was false andcaused by, for example, a drop in R-wave amplitude. In contrast, smallpeaks within asystole interval 323 that are out of phase with thepreceding R-R intervals might be P-waves during a true asystole causedby A-V block.

In some examples, processing circuitry 50 identifies N depolarizations322 preceding asystole interval 323, e.g., N consecutive depolarizations322 including the last depolarization 322D preceding asystole interval323. Based on the N preceding depolarizations 322, processing circuitry50 may determine N-1 intervals between the preceding depolarizations322, including intervals 324A and 324B (collectively,“inter-depolarization intervals 324”). N may be any integer, such asseven or thirteen. Within asystole interval 323, processing circuitry 50sets expected depolarization windows 326A-326C (collectively “expecteddepolarization windows 326”) and expected inter-depolarization windows328A-328C (collectively, “expected inter-depolarization windows 328”)based on inter-depolarization intervals 324. Although three of each typeof window are illustrated in the example of FIG. 16, other examples mayemploy more or fewer of each type of window, and/or different numbers ofwindows for the two types of windows.

In some examples, processing circuitry 50 determines a median or otherrepresentative value of inter-depolarization intervals 324. Processingcircuitry 50 may set windows 326 and 328 within asystole interval 323based on the representative value of inter-depolarization intervals 324.For example, processing circuitry 50 may set each of expecteddepolarization windows 326 to occur, e.g., be centered at a time thatis, a different integer multiple of the representative interval afterthe last preceding depolarization 322D. In one such example, processingcircuitry 50 may set expected depolarization window 326A to be therepresentative interval after depolarization 322D, expecteddepolarization window 326B to be two times the representative intervalafter depolarization 322D, and expected depolarization window 326C to bethree times the representative interval after depolarization 322D.Processing circuitry 50 may set each of expected inter-depolarizationwindows 328 to occur, e.g., be centered at a time that is, a differentnon-integer, e.g., fractional, multiple of the representative intervalafter the last preceding depolarization 322D. In one such example,processing circuitry 50 may set expected inter-depolarization window328A to be the one-half the representative interval after depolarization322D, expected inter-depolarization window 328B to be one and one-halftimes the representative interval after depolarization 322D, andexpected inter-depolarization window 328C to be two and one-half timesthe representative interval after depolarization 322D. The width ofwindows 326 and 328 may be set as a predetermined portion, e.g.,fraction or percentage, or the representative interval, and thepredetermined portion may be the same or different as between windows326 and windows 328.

Processing circuitry 50 determines a first energy value for expecteddepolarization windows 326 and a second energy value for expectedinter-depolarization windows 328. In some examples, processing circuitry50 determines an energy value for each of windows 326 and windows 328,and then determines a first mean, median, or other representative energyvalue of the energy values of windows 326, and a second representativeenergy value of the energy values of windows 328. Processing circuitry50 may employ any known technique for determining an energy of a signalwithin a window. In some examples, as an energy value for each of thewindows 326 and 328, processing circuitry 50 determines a difference,ratio, or other metric of comparison between a maximum amplitude ofcardiac EGM 320 and minimum amplitude of cardiac EGM 320 within thewindow.

Processing circuitry 50 further determines a difference, ratio, or othermetric of comparison between the first representative energy value forthe expected depolarization windows 326 and the second representativeenergy value for the expected inter-depolarization windows 328.Processing circuitry 50 determines whether the metric of comparisonsatisfies, e.g., is equal to or exceeds, a threshold. The firstrepresentative energy value being relatively high compared to the secondenergy level may indicate the presence of low amplitude depolarizations,e.g., R-waves, within asystole interval 323 that are in phase with therhythm prior to asystole interval 323, and that the suspected asystolewas a false asystole detection.

FIG. 17 is a flow diagram illustrating another example operation fordetermining whether an example false asystole criterion is satisfied.The example operation of FIG. 17 is described with reference to thecardiac EGM 320 and other data illustrated in FIG. 16.

According to the example of FIG. 17, processing circuitry 50 identifiesN depolarizations 322 preceding asystole interval 323 (340). Processingcircuitry 50 determines intervals 324 between the N precedingdepolarizations 322 (342). Processing circuitry 50 further sets expecteddepolarization windows 326 and expected inter-depolarization windows 328within asystole interval 323 based on the intervals 324, e.g., based oninteger and non-integer multiples, respectively, of a mean or median ofintervals 124 (344).

Processing circuitry 50 determines respective energy values for expecteddepolarization windows 326 and expected inter-depolarization windows328, e.g., a difference between a maximum amplitude and a minimumamplitude of cardiac EGM 320 within each window (346). Processingcircuitry 50 further determines a metric of comparison between theenergies of windows 326 and the energies of windows 328 (348). Forexample, processing circuitry 50 may determine a difference between amean of the energies of windows 326 and a mean of the energies ofwindows 328.

Processing circuitry 50 determines whether the metric of comparisonsatisfies the threshold, e.g., is equal to or greater than the threshold(350). Based on the metric of comparison satisfying the threshold (YESof 350), processing circuitry 50 may determine that the suspectedasystole episode is a false asystole (128). Based on the metric ofcomparison not satisfying the threshold (NO of 350), processingcircuitry 50 may proceed to application of another false asystoledetection criterion or, if there is not another false asystole detectioncriterion to apply, the operations of FIGS. 17 and 6 may end (124).

FIGS. 18A-18C are conceptual diagrams of another example medical system410 implanted within a patient 408. FIG. 1A is a front view of medicalsystem 410 implanted within patient 408. FIG. 1B is a side view ofmedical system 410 implanted within patient 408. FIG. 1C is a transverseview of medical device system 410 implanted within patient 408.

In some examples, the medical system 410 is an extravascular implantablecardioverter-defibrillator (EV-ICD) system implanted within patient 408.Medical system 410 includes IMD 412, which in the illustrated example isimplanted subcutaneously or submuscularly on the left midaxillary ofpatient 408, such that IMD 412 may be positioned on the left side ofpatient 408 above the ribcage. In some other examples, IMD 412 may beimplanted at other subcutaneous locations on patient 408 such as at apectoral location or abdominal location. IMD 412 includes housing 420that may form a hermetic seal that protects components of IMD 412. Insome examples, housing 420 of IMD 412 may be formed of a conductivematerial, such as titanium, or of a combination of conductive andnon-conductive materials, which may function as a housing electrode. IMD412 may also include a connector assembly (also referred to as aconnector block or header) that includes electrical feedthroughs throughwhich electrical connections are made between lead 422 and electroniccomponents included within the housing.

IMD 412 may provide the cardiac EGM sensing, asystole detection, andother functionality described herein with respect to IMD 10, and housing420 may house circuitries 50-62 and an antenna 26 (FIGS. 2 and 3) thatprovide such functionality. Housing 420 may also house therapy deliverycircuitry configured to generate therapeutic electric signals, such ascardiac pacing and anti-tachyarrhythmia shocks, for delivery to patient408. System 410 may include an external device 12 that may function withIMD 412 as described herein with respect to IMD 10 and system 2.

In the illustrated example, IMD 412 is connected to at least oneimplantable cardiac lead 422. Lead 422 includes an elongated lead bodyhaving a proximal end that includes a connector (not shown) configuredto be connected to IMD 412 and a distal portion that includes electrodes432A, 432B, 434A, and 434B. Lead 422 extends subcutaneously above theribcage from IMD 412 toward a center of the torso of patient 408. At alocation near the center of the torso, lead 422 bends or turns andextends intrathoracically superior under/below sternum 424. Lead 422thus may be implanted at least partially in a substernal space, such asat a target site between the ribcage or sternum 424 and heart 418. Inone such configuration, a proximal portion of lead 422 may be configuredto extend subcutaneously from IMD 12 toward sternum 24 and a distalportion of lead 22 may be configured to extend superior under or belowsternum 424 in the anterior mediastinum 426 (FIG. 1C).

For example, lead 422 may extend intrathoracically superior under/belowsternum 424 within anterior mediastinum 426. Anterior mediastinum 426may be viewed as being bounded posteriorly by pericardium 416, laterallyby pleurae 428, and anteriorly by sternum 424. In some examples, theanterior wall of anterior mediastinum 426 may also be formed by thetransversus thoracis and one or more costal cartilages. Anteriormediastinum 426 includes a quantity of loose connective tissue (such asareolar tissue), some lymph vessels, lymph glands, substernalmusculature (e.g., transverse thoracic muscle), and small vessels orvessel branches. In one example, the distal portion of lead 422 may beimplanted substantially within the loose connective tissue and/orsubsternal musculature of anterior mediastinum 426. In such examples,the distal portion of lead 422 may be physically isolated frompericardium 416 of heart 418. A lead implanted substantially withinanterior mediastinum 426 is an example of a substernal lead or, moregenerally, an extravascular lead.

The distal portion of lead 422 is described herein as being implantedsubstantially within anterior mediastinum 426. Thus, some of distalportion of lead 422 may extend out of anterior mediastinum 426 (e.g., aproximal end of the distal portion), although much of the distal portionmay be positioned within anterior mediastinum 426. In other embodiments,the distal portion of lead 422 may be implanted intrathoracically inother non-vascular, extra-pericardial locations, including the gap,tissue, or other anatomical features around the perimeter of andadjacent to, but not attached to, the pericardium 416 or other portionof heart 418 and not above sternum 424 or the ribcage. Lead 422 may beimplanted anywhere within the “substernal space” defined by theundersurface between the sternum and/or ribcage and the body cavity butnot including pericardium 416 or other portions of heart 418. Thesubsternal space may alternatively be referred to by the terms“retrosternal space” or “mediastinum” or “infrasternal” as is known tothose skilled in the art and includes the anterior mediastinum 426. Thesubsternal space may also include the anatomical region described inBaudoin, Y. P., et al., entitled “The superior epigastric artery doesnot pass through Larrey's space (trigonum sternocostale).”Surg.Radiol.Anat. 25.3-4 (2003): 259-62 as Larrey's space. In otherwords, the distal portion of lead 422 may be implanted in the regionaround the outer surface of heart 418, but not attached to heart 418.For example, the distal portion of lead 422 may be physically isolatedfrom pericardium 416.

Lead 422 may include an insulative lead body having a proximal end thatincludes connector 430 configured to be connected to IMD 412 and adistal portion that includes one or more electrodes. As shown in FIG.18A, the one or more electrodes of lead 422 may include electrodes 432A,432B, 434A, and 434B, although in other examples, lead 422 may includemore or fewer electrodes. Lead 422 also includes one or more conductorsthat form an electrically conductive path within the lead body andinterconnect the electrical connector and respective ones of theelectrodes.

Electrodes 432A, 432B may be defibrillation electrodes (individually orcollectively “defibrillation electrode(s) 432”). Although electrodes 432may be referred to herein as “defibrillation electrodes 432,” electrodes432 may be configured to deliver other types of anti-tachyarrhythmiashocks, such as cardioversion shocks. Though defibrillation electrodes432 are depicted in FIGS. 18A-18C as coil electrodes for purposes ofclarity, it is to be understood that defibrillation electrodes 432 maybe of other configurations in other examples. Defibrillation electrodes432 may be located on the distal portion of lead 422, where the distalportion of lead 422 is the portion of lead 422 that is configured to beimplanted extravascularly below the sternum 424.

Lead 422 may be implanted at a target site below or along sternum 424such that a therapy vector is substantially across a ventricle of heart418. In some examples, a therapy vector (e.g., a shock vector fordelivery of anti-tachyarrhythmia shock) may be between defibrillationelectrodes 432 and a housing electrode formed by or on IMD 412. Thetherapy vector may, in one example, be viewed as a line that extendsfrom a point on defibrillation electrodes 432 (e.g., a center of one ofthe defibrillation electrodes 432) to a point on a housing electrode ofIMD 412. As such, it may be advantageous to increase an amount of areaacross which defibrillation electrodes 432 (and therein the distalportion of lead 422) extends across heart 418. Accordingly, lead 422 maybe configured to define a curving distal portion as depicted in FIG.18A. In some examples, the curving distal portion of lead 22 may helpimprove the efficacy and/or efficiency of pacing, sensing, and/ordefibrillation to heart 418 by IMD 412.

Electrodes 434A, 434B may be pace/sense electrodes (individually orcollectively, “pace/sense electrode(s) 434”) located on the distalportion of lead 422. Electrodes4 34 are referred to herein as pace/senseelectrodes as they generally are configured for use in delivery ofpacing pulses and/or sensing of cardiac electrical signals. In someinstances, electrodes 434 may provide only pacing functionality, onlysensing functionality, or both pacing functionality and sensingfunctionality. In the example illustrated in FIG. 18A and FIG. 18B,pace/sense electrodes 434 are separated from one another bydefibrillation electrode 432B. In other examples, however, pace/senseelectrodes 434 may be both distal of defibrillation electrode 432B orboth proximal of defibrillation electrode 432B. In examples in whichlead 422 includes more or fewer electrodes 432, 434, such electrodes maybe positioned at other locations on lead 422.

In the example of FIG. 18A, the distal portion of lead 422 is aserpentine shape that includes two “C” shaped curves, which together mayresemble the Greek letter epsilon, “c.” Defibrillation electrodes 432are each carried by one of the two respective C-shaped portions of thelead body distal portion. The two C-shaped curves extend or curve in thesame direction away from a central axis of the lead body. In someexamples, pace/sense electrodes 434 may be approximately aligned withthe central axis of the straight, proximal portion of lead 422. In suchexamples, mid-points of defibrillation electrodes 432 are laterallyoffset from pace/sense electrodes 434. Other examples ofextra-cardiovascular leads including one or more defibrillationelectrodes and one or more pace/sense electrodes 434 carried by curving,serpentine, undulating or zig-zagging distal portion of lead 422 alsomay be implemented using the techniques described herein. In someexamples, the distal portion of lead 422 may be straight (e.g., straightor nearly straight).

Deploying lead 422 such that electrodes 432, 434 are at the depictedpeaks and valleys of serpentine shape may provide access to preferredsensing or therapy vectors. Orienting the serpentine shaped lead suchthat pace/sense electrodes 434 are closer to heart 418 may providebetter electrical sensing of the cardiac signal and/or lower pacingcapture thresholds than if pace/sense electrodes 434 were orientedfurther from heart 418. The serpentine or other shape of the distalportion of lead 422 may have increased fixation to patient 408 as aresult of the shape providing resistance against adjacent tissue when anaxial force is applied. Another advantage of a shaped distal portion isthat electrodes 432, 434 may have access to greater surface area over ashorter length of heart 418 relative to a lead having a straighterdistal portion.

In some examples, the elongated lead body of lead 422 may include one ormore elongated electrical conductors (not illustrated) that extendwithin the lead body from the connector at the proximal lead end toelectrodes 432, 434 located along the distal portion of lead 422. Theone or more elongated electrical conductors contained within the leadbody of lead 422 may engage with respective ones of electrodes 432, 434.The conductors may electrically couple to circuitry, such as a therapydelivery circuitry and sensing circuitry 52, of IMD 412 via connectionsin connector assembly. The electrical conductors transmit therapy fromthe therapy delivery circuitry to one or more of electrodes 432, 434,and transmit sensed cardiac EGMs from one or more of electrodes 432, 434to sensing circuitry 52 within IMD 412.

In general, IMD 412 may sense cardiac EGMs, such as via one or moresensing vectors that include combinations of pace/sense electrodes 434and/or a housing electrode of IMD 412. In some examples, IMD 412 maysense cardiac EGMs using a sensing vector that includes one or both ofthe defibrillation electrodes 432 and/or one of defibrillationelectrodes 432 and one of pace/sense electrodes 434 or a housingelectrode of IMD 412. Medical system 410, including processing circuitryof IMD 412 and/or external device 12, may perform any of the techniquesdescribed herein for determining whether asystole detection and falseasystole detection criteria are satisfied, e.g., based on cardiac EGMssensed via extravascular electrodes 432, 434. Cardiac EGMs sensed viaextravascular electrodes may include noise, e.g., due to changingcontact with tissue and/or orientation relative to heart, in a similarmanner as described herein with respect to subcutaneous electrodes. Ingeneral, when electrodes are not fixed directly to the myocardium,motion, e.g., respiratory motion, can cause variability indepolarization amplitudes and other noise that may lead to falseasystole detections. The techniques described herein may be implementedwith cardiac EGMs sensed via subcutaneous electrodes, cutaneouselectrodes, substernal electrodes, extravascular electrodes,intra-muscular electrodes, or any electrodes positioned in (or incontact with) any tissue of a patient.

The techniques described in this disclosure may be implemented, at leastin part, in hardware, software, firmware, or any combination thereof.For example, various aspects of the techniques may be implemented withinone or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalentintegrated or discrete logic QRS circuitry, as well as any combinationsof such components, embodied in external devices, such as physician orpatient programmers, stimulators, or other devices. The terms“processor” and “processing circuitry” may generally refer to any of theforegoing logic circuitry, alone or in combination with other logiccircuitry, or any other equivalent circuitry, and alone or incombination with other digital or analog circuitry.

For aspects implemented in software, at least some of the functionalityascribed to the systems and devices described in this disclosure may beembodied as instructions on a computer-readable storage medium such asRAM, DRAM, SRAM, magnetic discs, optical discs, flash memories, or formsof EPROM or EEPROM. The instructions may be executed to support one ormore aspects of the functionality described in this disclosure.

In addition, in some aspects, the functionality described herein may beprovided within dedicated hardware and/or software modules. Depiction ofdifferent features as modules or units is intended to highlightdifferent functional aspects and does not necessarily imply that suchmodules or units must be realized by separate hardware or softwarecomponents. Rather, functionality associated with one or more modules orunits may be performed by separate hardware or software components, orintegrated within common or separate hardware or software components.Also, the techniques could be fully implemented in one or more circuitsor logic elements. The techniques of this disclosure may be implementedin a wide variety of devices or apparatuses, including an IMD, anexternal programmer, a combination of an IMD and external programmer, anintegrated circuit (IC) or a set of ICs, and/or discrete electricalcircuitry, residing in an IMD and/or external programmer.

What is claimed is:
 1. A medical device comprising: a plurality ofelectrodes configured to sense a cardiac electrogram of a patient; andprocessing circuitry configured to: determine that an asystole detectioncriterion is satisfied based on not identifying a cardiac depolarizationin the cardiac electrogram during a time interval; based on thedetermination that the asystole detection is satisfied, determinewhether one or more false asystole detection criteria are satisfiedbased on the cardiac electrogram signal; and withhold an indication ofan asystole episode for the patient based on a determination that atleast one of the one or more false asystole detection criteria issatisfied, wherein the one or more false asystole detection criteriacomprises a reduced amplitude threshold criterion for detecting cardiacdepolarizations in the cardiac electrogram, wherein, to determine thatthe reduced amplitude threshold criterion is satisfied, the processingcircuitry is configured to: identify a plurality of cardiacdepolarizations occurring in the cardiac electrogram preceding the timeinterval; determine an amplitude for each cardiac depolarization of theplurality of identified cardiac depolarizations; and determine a reducedamplitude threshold based on the determined amplitudes of the pluralityof identified cardiac depolarizations.
 2. The medical device of claim 1,wherein, to determine that the reduced amplitude threshold criterion issatisfied, the processing circuitry is configured to: compare thereduced amplitude threshold to the cardiac electrogram during the timeinterval; and determine that a threshold number of cardiacdepolarizations is identified in the cardiac electrogram during the timeinterval based on the comparison.
 3. The medical device of claim 1,wherein the processing circuitry is configured to: determine arepresentative amplitude based on the amplitudes of each the pluralityof identified cardiac depolarizations; and determine the reducedamplitude threshold as a predetermined portion of the representativeamplitude.
 4. The medical device of claim 1, wherein the one or morefalse asystole detection criteria comprises a decaying noise criterion.5. The medical device of claim 4, wherein, to determine that thedecaying noise criterion is satisfied, the processing circuitry isconfigured to: calculate an area-under-the-curve value for the cardiacelectrogram during at least a portion of the time interval; anddetermine that the area-under-the-curve value satisfies anarea-under-the-curve threshold.
 6. The medical device of claim 4,wherein, to determine that the decaying noise criterion is satisfied,the processing circuitry is configured to: determine a differentialsignal of the cardiac electrogram during at least a portion of the timeinterval; for each of a plurality of samples of the differential signal,determine whether a sign of the sample is positive or negative; anddetermine that an amount of samples having one of the signs satisfies acommon sign threshold.
 7. The medical device of claim 1, wherein the oneor more false asystole detection criteria further comprises a precedingdepolarization variability criterion, wherein, to determine that thepreceding depolarization variability criterion is satisfied, theprocessing circuitry is configured to: identify a plurality of cardiacdepolarizations occurring in the cardiac electrogram preceding the timeinterval; determine an amplitude for each of the plurality of identifiedcardiac depolarizations; determine a variability of the amplitudes; anddetermine that the variability satisfies a variability threshold.
 8. Themedical device of claim 7, wherein, to determine the variability of theamplitudes, the processing circuitry is configured to: determine amaximum amplitude of the plurality of amplitudes; determine arepresentative amplitude of the plurality of amplitudes; and determine ametric of comparison of the maximum amplitude to the representativeamplitude.
 9. The medical device of claim 1, wherein the one or morefalse asystole detection criteria further comprises an energy patterncriterion, wherein, to determine that the energy pattern criterion issatisfied, the processing circuitry is configured to: identify aplurality of cardiac depolarizations occurring in the cardiacelectrogram preceding the time interval; determine one or more intervalsbetween adjacent ones of the plurality of cardiac depolarizations; basedon the determined intervals, identify one or more expected cardiacdepolarization windows and one or more expected inter-depolarizationwindows within the time interval; determine a first energy of the one ormore cardiac depolarization windows and a second energy of the one ormore inter-depolarization windows; determine a metric of comparison ofthe first energy to the second energy; and determine that the metric ofcomparison satisfies a threshold.
 10. The medical device of claim 1,wherein the processing circuitry is configured to: determine a count ofinstances of satisfaction of the asystole detection criterion within atime period; and determine whether the count satisfies at least oneasystole count criterion, wherein the processing circuitry is configuredto determine whether the one or more false asystole detection criteriaare satisfied based on determining that the count satisfies at least oneasystole count criterion.
 11. The medical device of claim 1, wherein theplurality of electrodes are configured for subcutaneous implantation,and the cardiac electrogram comprises a subcutaneous cardiacelectrogram.
 12. A medical system comprising: a medical devicecomprising a plurality of electrodes configured to sense a cardiacelectrogram of a patient; one or more computing devices configured tocommunicate with the medical device and comprising processing circuitryconfigured to: determine that an asystole detection criterion issatisfied based on not identifying a cardiac depolarization in thecardiac electrogram during a time interval; based on the determinationthat the asystole detection is satisfied, determine whether one or morefalse asystole detection criteria are satisfied based on the cardiacelectrogram signal; and withhold an indication of an asystole episodefor the patient based on a determination that at least one of the one ormore false asystole detection criteria is satisfied, wherein the one ormore false asystole detection criteria comprises a reduced amplitudethreshold criterion for detecting cardiac depolarizations in the cardiacelectrogram, wherein, to determine that the reduced amplitude thresholdcriterion is satisfied, the processing circuitry is configured to:identify a plurality of cardiac depolarizations occurring in the cardiacelectrogram preceding the time interval; determine an amplitude for eachcardiac depolarization of the plurality of identified cardiacdepolarizations; and determine a reduced amplitude threshold based onthe determined amplitudes of the plurality of identified cardiacdepolarizations.
 13. The medical system of claim 12, wherein, todetermine that the reduced amplitude threshold criterion is satisfied,the processing circuitry is configured to: compare the reduced amplitudethreshold to the cardiac electrogram during the time interval; anddetermine that a threshold number of cardiac depolarizations isidentified in the cardiac electrogram during the time interval based onthe comparison.
 14. The medical system of claim 12, wherein theprocessing circuitry is configured to: determine a representativeamplitude based on the amplitudes of each the plurality of identifiedcardiac depolarizations; and determine the reduced amplitude thresholdas a predetermined portion of the representative amplitude.
 15. Themedical system of claim 12, wherein the one or more false asystoledetection criteria comprises a decaying noise criterion.
 16. The medicalsystem of claim 15, wherein, to determine that the decaying noisecriterion is satisfied, the processing circuitry is configured to:calculate an area-under-the-curve value for the cardiac electrogramduring at least a portion of the time interval; and determine that thearea-under-the-curve value satisfies an area-under-the-curve threshold.17. The medical system of claim 15, wherein, to determine that thedecaying noise criterion is satisfied, the processing circuitry isconfigured to: determine a differential signal of the cardiacelectrogram during at least a portion of the time interval; for each ofa plurality of samples of the differential signal, determine whether asign of the sample is positive or negative; and determine that an amountof samples having one of the signs satisfies a common sign threshold.18. The medical system of claim 12, wherein the one or more falseasystole detection criteria further comprises a preceding depolarizationvariability criterion, wherein, to determine that the precedingdepolarization variability criterion is satisfied, the processingcircuitry is configured to: identify a plurality of cardiacdepolarizations occurring in the cardiac electrogram preceding the timeinterval; determine an amplitude for each of the plurality of identifiedcardiac depolarizations; determine a variability of the amplitudes; anddetermine that the variability satisfies a variability threshold. 19.The medical system of claim 12, wherein the one or more false asystoledetection criteria further comprises an energy pattern criterion,wherein, to determine that the energy pattern criterion is satisfied,the processing circuitry is configured to: identify a plurality ofcardiac depolarizations occurring in the cardiac electrogram precedingthe time interval; determine one or more intervals between adjacent onesof the plurality of cardiac depolarizations; based on the determinedintervals, identify one or more expected cardiac depolarization windowsand one or more expected inter-depolarization windows within the timeinterval; determine a first energy of the one or more cardiacdepolarization windows and a second energy of the one or moreinter-depolarization windows; determine a metric of comparison of thefirst energy to the second energy; and determine that the metric ofcomparison satisfies a threshold.
 20. A non-transitory computer-readablestorage medium comprising instructions that, when executed by processingcircuitry, cause the processing circuitry to: determine that an asystoledetection criterion is satisfied based on not identifying a cardiacdepolarization in a cardiac electrogram sensed by a medical deviceduring a time interval; determine, based on the determination that theasystole detection is satisfied, that one or more false asystoledetection criteria are satisfied based on the cardiac electrogramsignal; and withhold an indication of an asystole episode for thepatient based on a determination that at least one of the one or morefalse asystole detection criteria is satisfied, wherein the one or morefalse asystole detection criteria comprises a reduced amplitudethreshold criterion for detecting cardiac depolarizations in the cardiacelectrogram, wherein, to determine that the reduced amplitude thresholdcriterion is satisfied, the instructions cause the processing circuitryto: identify a plurality of cardiac depolarizations occurring in thecardiac electrogram preceding the time interval; determine an amplitudefor each cardiac depolarization of the plurality of identified cardiacdepolarizations; and determine a reduced amplitude threshold based onthe determined amplitudes of the plurality of identified cardiacdepolarizations.
 21. A medical device comprising: a plurality ofelectrodes configured to sense a cardiac electrogram of a patient; meansfor determining, based on a determination that an asystole detectioncriterion is satisfied, whether one or more false asystole detectioncriterion is satisfied based on the cardiac electrogram signal; andprocessing circuitry configured to: determine that the asystoledetection criterion is satisfied based on not identifying a cardiacdepolarization in the cardiac electrogram during a time interval; andwithhold an indication of an asystole episode for the patient based on adetermination that at least one of the one or more false asystoledetection criteria is satisfied, wherein the one or more false asystoledetection criteria comprises a reduced amplitude threshold criterion fordetecting cardiac depolarizations in the cardiac electrogram, wherein,to determine that the reduced amplitude threshold criterion issatisfied, the processing circuitry is configured to: identify aplurality of cardiac depolarizations occurring in the cardiacelectrogram preceding the time interval; determine an amplitude for eachcardiac depolarization of the plurality of identified cardiacdepolarizations; and determine a reduced amplitude threshold based onthe determined amplitudes of the plurality of identified cardiacdepolarizations.